| CTRI Number |
CTRI/2026/03/106050 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Adaptation of Feeding and Eating in AutiSm Together (FEAST) for the Indian population |
|
Scientific Title of Study
|
Cross Cultural Adaptation and Pre-testing of Feeding and Eating in AutiSm Together (FEAST) for the Indian population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saakshi Trisha Neha Pinto |
| Designation |
Masters in Speech Language Pathology |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing ,Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9481921033 |
| Fax |
|
| Email |
saakshi.trisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Department of Speech and Hearing ,Manipal College of Health Professions (MCHP) |
| Address |
Department of Speech and Hearing ,Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Department of Speech and Hearing ,Manipal College of Health Professions (MCHP) |
| Address |
Department of Speech and Hearing ,Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9986448718 |
| Fax |
|
| Email |
shivani.tiwari@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saakshi Trisha Neha Pinto |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saakshi Trisha Neha Pinto |
Manipal College of Health Professions (MCHP) |
Department of Speech and Hearing, room number 416 Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA |
9481921033
saakshi.trisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health care Professionals (Phase 1)
Parents of children with Autism Spectrum Disorder (Phase 2) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Adaptation (Phase I)
Inclusion criteria
1.All professionals should have a graduate degree and a minimum of two years’ experience working with autistic children in India
2.Parents (either mother, father) or any other primary caregiver who is directly involved in child’s caregiving of children with autism, who can read and write in English
Pre-testing (Phase II)
Inclusion criteria
1.Parents of children with autism (between the ages of 2 and 12 years), who can read and write English |
|
| ExclusionCriteria |
| Details |
Adaptation (Phase I)
Exclusion criteria
1.Professionals without experience of working with autistic children
2.Parents of children with autism with severe motor, visual, hearing, or persistent health issues, intellectual disability (moderate to severe).
Pre-testing (Phase II)
Exclusion criteria
1.Parents of children with autism with severe motor, visual, hearing, or persistent health issues,
intellectual disability (moderate to severe).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
For Content Validation, Content Validity Index (CVI) will be used Inter-rater
reliability will be assessed using Kappa and the Internal consistency will be checked by
Cronbach’s Alpha. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
While there are plenty of tools for feeding assessment in children, specific tools for feeding assessment in children with autism are limited. FEAST is one of the comprehensive tools for feeding assessment in children with autism, originally developed for Western dietary habits and does not reflect India’s diverse dietary habits, family structures, or environmental factors. The lack of cultural sensitivity and adaption hinders accurate diagnosis as well as intervention for feeding disorders in children with autism in India. Hence, this study is being conducted to have a culturally suitable tool that helps in identification of underlying etiology in children with autism in the Indian population.
Addressing feeding difficulties in children with ASD is a complex challenge that demands a multifaceted strategy. While the scales offer valuable insights, there are still substantial gaps, particularly regarding the integration of sensory and Oromotor factors, the creation of standardized scoring systems, cultural adaptations, and the examination of relational dynamics. The FEAST tool stands out as a comprehensive assessment tool that bridges these gaps and pushes the field of feeding assessments in autism forward. It’s designed to evaluate mealtime challenges across four key areas: Sensory Processing, Oral Motor Skills, Behaviour, and Gastrointestinal Health. Not only does it provide total severity score and subscale scores to help with clinical planning, but it also demonstrates good construct validity and internal consistency, capturing unique feeding-related aspects that other tools don’t address.
By filling this gap, FEAST comprehensively assesses the various factors that impact feeding in ASD. Studies show that the FEAST Total Score and Behaviour subscale correlate well with BAMBIC and STEPCHILD, confirming its measure of general feeding problems (St John et al., 2025). The Sensory, Oral Motor, and Gastrointestinal Health subscales show weak correlations with these other tools, which is interpreted as a benefit. It suggests that FEAST is capturing additional, distinct factors related to feeding challenges that other tools miss, providing a more detailed view.
Given the lack of resources in the current Indian context, FEAST would serve as a efficient tool in assessing feeding and eating behaviours in children with Autism |